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一品紅(300723.SZ):注射用奧美拉唑鈉20mg、40mg雙規格通過一致性評價
格隆匯 05-26 15:47

格隆匯5月26日丨一品紅(300723.SZ)公佈,公司全資子公司廣州一品紅製藥有限公司於近日收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知》,公司生產注射用奧美拉唑鈉20mg40mg雙規格通過仿製藥質量和療效一致性評價。

公司獲批的注射用奧美拉唑鈉適應症如下

主要用於:①消化性潰瘍出血、吻合口潰瘍出血②應急狀態時併發的急性胃黏膜損害、非甾體類抗炎藥引起的急性胃黏膜損傷③預防重症疾病(如腦出血、嚴重創傷等)應激狀態及胃手術後引起的上消化道出血等④作為當口服療法不適用時下列病症的替代療法十二指腸潰瘍、胃潰瘍、反流性食管炎及Zollinger-Ellison綜合徵。

奧美拉唑是首個上市的質子泵抑制劑,通過抑制胃壁細胞H+-K+-ATP酶的活性而抑制胃酸分泌。注射用奧美拉唑鈉至今已在臨牀應用超過20年,臨牀應用循證豐富,已被國內外多部權威指南或專家共識推薦作為消化道潰瘍的首選藥物之一

米內網數據顯示,2020年注射用奧美拉唑鈉在中國城市公立醫院、縣級公立醫院、城市社區中心及鄉鎮衞生院(簡稱中國公立醫療機構)終端的銷售額為50億元,在同類治療消化性潰瘍藥注射產品中銷量第一。

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